A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- Safety (clinical and laboratory parameters)
研究概览
简要总结
This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.
详细描述
This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Moderately to severely active rheumatoid arthritis
- •Inadequate response to previous treatment with an anti-TNF agent
- •Receiving methotrexate for at least 12 wks before study
排除标准
- •Previous treatment with tocilizumab
- •Previous treatment with other IL-6 receptor inhibitors
- •Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks
- •Conditions noted in the tocilizumab prescribing information
结局指标
主要结局
Safety (clinical and laboratory parameters)
时间窗: Throughout the study until week 10
Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count
次要结局
- Treatment emergent adverse events(Throughout the study until week 10)